Fentanyl

Hazard4P3B0T1RiskCannot be excluded

Information

The T-value in the PBT index refers to acute toxicity for the trophic level crustacean 11.1 mg fentanyl/L. This information and the information about P and B are from Fass environmental information for Durogesic (downloaded 2018-05-22). Data from the assessment report, see below, also gives the number 0 for B. The risk "cannot be excluded" is from Goodpoints report.

In Sweden fentanyl has been found in surface waters at very low levels, but because of the expected high potency and expected bioconcentration, risk can not be excluded. Mechanism-based efficacy data is lacking.

Fentanyl has previously been found in purified wastewater in Stockholm County (2005-2012).

Assessment report

Hazard

Persistence: No information.

Bioaccumulation: log Kow = 2.96, Conclusion: "Potential PBT (N)".

Chronic toxicity: No information.

Risk

"The applicant has provided a suitable review of the environmental risk implications of the use of fentanyl. The estimation of exposure (Phase I) of fentanyl does not raise concern with respect to the PEC action limit for surface water, this is 0.0004 μg/L, and so a Phase II assessment is not required. LogKow is also below 4.5, and so fentanyl is not considered to be a PBT substance. Therefore fentanyl is not expected to pose a risk to the environment. The ERA is acceptable.

Fass environmental information

Fass environmental information for Durogesic (downloaded 2018-05-22).

Hazard

Persistence: "Fentanyl is not readily biodegradable in a biodegradability test according to OECD No. 301 F: “Manometric respirometry test”. Within the given test period of 28 days and at the given test conditions fentanyl HCl cannot be regards as readily biodegradable. Consequently, the medicine is potentially persistent."